MAH | Marketing Authorisation Holder

Q: MAH | Marketing Authorisation Holder

Marketing Authorisation Holder The Marketing Authorisation Holder (MAH) is the legal entity or person holding a medicine’s MA . As the legal responsible party, the MAH must ensure regulatory compliance, pharmacovigilance , quality, and product availability. While some activities (distribution, exploitation) can be delegated, the MAH remains legally accountable for the medicine’s safety and efficacy on the market.

Marketing Authorisation Holder

The Marketing Authorisation Holder (MAH) is the legal entity or person holding a medicine’s MA.

As the legal responsible party, the MAH must ensure regulatory compliance, pharmacovigilance, quality, and product availability. While some activities (distribution, exploitation) can be delegated, the MAH remains legally accountable for the medicine’s safety and efficacy on the market.